Two-stage method for treating calcified lesions within the wall of a blood vessel

ABSTRACT

A two-stage method is disclosed for treating calcified lesions within a wall of a blood vessel. The first step includes breaking apart a calcified lesion using a plurality of shockwaves generated in an angioplasty balloon of an angioplasty catheter device. The angioplasty balloon is dilated via a fluid to a first extent to fit against at least a portion of the wall of the blood vessel. A plurality of electrical pulses are delivered to a pair of electrodes disposed within the fluid inside the balloon. The electrical pulses have an amplitude sufficient to create plasma arcs in the fluid to generate shockwaves that are conducted through the fluid and through the balloon to the blood vessel, to crack the calcified lesion. After breaking apart the calcified lesion, the angioplasty balloon is allowed to further expand to a second extent greater than the first extent, thereby reshaping an opening in the blood vessel.

PRIORITY CLAIM

The present application is a continuation-in-part of U.S. patent application Ser. No. 16/028,225, filed Jul. 5, 2018, which is in turn a continuation of U.S. patent application Ser. No. 14/660,539, filed Mar. 17, 2015, now issued as U.S. Pat. No. 10,039,561 on Aug. 7, 2018, which is a continuation of U.S. patent application Ser. No. 13/646,570, filed Oct. 5, 2012, now issued as U.S. Pat. No. 9,011,462, on Apr. 21, 2015, which is a continuation of U.S. patent application Ser. No. 12/482,995, filed Jun. 11, 2009, now issued as U.S. Pat. No. 8,956,371 on Feb. 17, 2015, which_claims the benefit of U.S. Provisional Patent Application Ser. No. 61/061,170, filed Jun. 13, 2008, each of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention relates to a treatment system for percutaneous coronary angioplasty or peripheral angioplasty in which a dilation catheter is used to cross a lesion in order to dilate the lesion and restore normal blood flow in the artery. It is particularly useful when the lesion is a calcified lesion in the wall of the artery. Calcified lesions require high pressures (sometimes as high as 10-15 or even 30 atmospheres) to break the calcified plaque and push it back into the vessel wall. With such pressures comes trauma to the vessel wall which can contribute to vessel rebound, dissection, thrombus formation, and a high level of restenosis. Non-concentric calcified lesions can result in undue stress to the free wall of the vessel when exposed to high pressures. An angioplasty balloon when inflated to high pressures can have a specific maximum diameter to which it will expand but the opening in the vessel under a concentric lesion will typically be much smaller. As the pressure is increased to open the passage way for blood the balloon will be confined to the size of the open in the calcified lesion (before it is broken open). As the pressure builds a tremendous amount of energy is stored in the balloon until the calcified lesion breaks or cracks. That energy is then released and results in the rapid expansion of the balloon to its maximum dimension and may stress and injure the vessel walls.

SUMMARY OF THE INVENTION

In an illustrative embodiment, the invention provides a two-stage method is used for treating calcified lesions within a wall of a blood vessel in a patient. In a first stage, the calcified lesion within the wall of the blood vessel is cracked using a plurality of shockwaves generated in an angioplasty balloon of an angioplasty catheter device. The angioplasty catheter device may include a guidewire sheath disposed on a guidewire. The angioplasty balloon is dilated via a fluid to a first extent to fit against the wall of the blood vessel. A plurality of electrical pulses are supplied to an electrode pair disposed within the angioplasty balloon and exposed to the fluid. Each pulse has an amplitude sufficient to create a plasma in the fluid. The plurality of pulses create a plurality of plasma arcs at the electrode pair such that the plurality of shockwaves is conducted through the fluid and through the angioplasty balloon to the blood vessel, thereby delivering mechanical energy to the calcified lesion to crack the calcified lesion. After breaking apart the calcified lesion, the angioplasty balloon is allowed to expand to a second extent greater than the first extent, thereby redistributing particles of the calcified lesion in the wall of the blood vessel and reshaping an opening in the blood vessel.

In another illustrative embodiment, a method is used for treating calcified lesions within the wall of a blood vessel. The method includes inserting a guide wire into the blood vessel. An angioplasty catheter having a guidewire sheath is advanced into the blood vessel over the guide wire. The catheter includes a fluid-fillable angioplasty balloon and a shockwave generator located within the angioplasty balloon. The shockwave generator is defined by a pair of spaced apart electrodes disposed inside the angioplasty balloon and exposed to the fluid. The angioplasty balloon is expanded with the fluid so that the angioplasty balloon presses against at least a portion of the calcified wall of the blood vessel. At this stage, one or more electrical pulses are supplied to the shockwave generator. Each pulse is sufficient to create a plasma arc between the pair of spaced apart electrodes resulting in a mechanical shock wave within the angioplasty balloon that passes through the fluid, through the angioplasty balloon, and into the calcified wall of the blood vessel to crack calcified lesions within the calcified wall of the blood vessel. Thereafter, the balloon is further expanded to displace fractured calcification in the wall of the blood vessel, thereby reshaping the blood vessel.

The invention provides a catheter that comprises an elongated carrier, a dilating balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon.

The at least one electrode may include a single metallic electrode of a pair of metallic electrodes. The electrodes may be radially displaced from each other or longitudinally displaced from each other. The at least one electrode may be formed of stainless steel.

The balloon may be formed of non-compliant material or of compliant material. The dilating balloon may have at least one stress riser carried on its surface.

The catheter may further comprise a sensor that senses reflected energy. The sensor may be distal to the at least one electrode. The sensor may be disposed on the carrier.

The catheter may further comprise a reflector within the dilating balloon that focuses the shock waves. The reflector may form one of the at least one electrodes. The catheter has a center line and the reflector may be arranged to focus the shock waves off of the catheter center line.

The fluid may be saline. The fluid may include an x-ray contrast.

The catheter may further include a lumen for receiving a guide wire. The lumen may be defined by the carrier.

The invention further provides a system comprising a catheter including an elongated carrier, a dilating balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further comprises a power source that provides electrical energy to the arc generator.

The power source is preferably arranged to provide pulsed high voltage. The power source may be arranged to provide high voltage pulses having selectable pulse durations, selectable voltage amplitudes, and/or selectable pulse repetition rates.

The system may further comprise an R wave detector that synchronizes the mechanical shock waves with cardiac R waves.

The at least one electrode may include a single metallic electrode of a pair of metallic electrodes. The electrodes may be radially displaced from each other or longitudinally displaced from each other. The at least one electrode may be formed of stainless steel.

The balloon may be formed of non-compliant material or of compliant material. The dilating balloon may have at least one stress riser carried on its surface.

The catheter may further comprise a sensor that senses reflected energy. The sensor may be distal to the at least one electrode. The sensor may be disposed on the carrier.

The catheter may further comprise a reflector within the dilating balloon that focuses the shock waves. The reflector may form one of the at least one electrodes. The catheter has a center line and the reflector may be arranged to focus the shock waves off of the catheter center line.

The fluid may be saline. The fluid may include an x-ray contrast.

The catheter may further include a lumen for receiving a guide wire. The lumen may be defined by the carrier.

The invention further provides a method comprising the step of providing a catheter including an elongated carrier, a dilating balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The method further comprises the steps of inserting the catheter into a body lumen of a patient adjacent an obstruction of the body lumen, admitting fluid into the balloon, and applying high voltage pulses to the arc generator to form a series of mechanical shocks within the balloon.

The method may include the further step of detecting cardiac R waves of the patient's heart, and synchronizing the mechanical shocks with the detected R waves.

The method may further include the step of varying one of the repetition rate, amplitude and duration of the high voltage pulses to vary the intensity of the mechanical shock waves.

The method may include the further step of sensing reflected energy within the catheter.

The method may include the further step of placing a guide wire into the body lumen and guiding the catheter into the body lumen along the guide wire.

The method may include the further step of focusing the mechanical shockwaves. The mechanical shockwaves may be focused away from the catheter center axis.

The method may include the further steps of adding an x-ray contrast to the fluid and visualizing the catheter under fluoroscopy.

BRIEF DESCRIPTION OF THE DRAWINGS

For illustration and not limitation, some of the features of the present invention are set forth in the appended claims. The various embodiments of the invention, together with representative features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:

FIG. 1 is a view of the therapeutic end of a typical prior art over-the-wire angioplasty balloon catheter.

FIG. 2 is a side view of a dilating angioplasty balloon catheter with two electrodes within the balloon attached to a source of high voltage pulses according to one embodiment of the invention.

FIG. 3 is a schematic of a high voltage pulse generator.

FIG. 3A shows voltage pulses that may be obtained with the generator of FIG. 3.

FIG. 4 is a side view of the catheter of FIG. 2 showing an arc between the electrodes and simulations of the shock wave flow.

FIG. 5 is a side view of a dilating catheter with insulated electrodes within the balloon and displaced along the length of the balloon according to another embodiment of the invention.

FIG. 6 is a side view of a dilating catheter with insulated electrodes within the balloon displaced with a single pole in the balloon and a second being the ionic fluid inside the balloon according to a further embodiment of the invention.

FIG. 7 is a side view of a dilating catheter with insulated electrodes within the balloon and studs to reach the calcification according to a still further embodiment of the invention.

FIG. 8 is a side view of a dilating catheter with insulated electrodes within the balloon with raised ribs on the balloon according to still another embodiment of the invention.

FIG. 8A is a front view of the catheter of FIG. 8.

FIG. 9 is a side view of a dilating catheter with insulated electrodes within the balloon and a sensor to detect reflected signals according to a further embodiment of the invention.

FIG. 10 is a pressure volume curve of a prior art balloon breaking a calcified lesion.

FIG. 10A is a sectional view of a balloon expanding freely within a vessel.

FIG. 10B is a sectional view of a balloon constrained to the point of breaking in a vessel.

FIG. 10C is a sectional view of a balloon after breaking within the vessel.

FIG. 11 is a pressure volume curve showing the various stages in the breaking of a calcified lesion with shock waves according to an embodiment of the invention.

FIG. 11A is a sectional view showing a compliant balloon within a vessel.

FIG. 11B is a sectional view showing pulverized calcification on a vessel wall.

FIG. 12 illustrates shock waves delivered through the balloon wall and endothelium to a calcified lesion.

FIG. 13 shows calcified plaque pulverized and smooth a endothelium restored by the expanded balloon after pulverization.

FIG. 14 is a schematic of a circuit that uses a surface EKG to synchronize the shock wave to the “R” wave for treating vessels near the heart.

FIG. 15 is a side view, partly cut away, of a dilating catheter with a parabolic reflector acting as one electrode and provides a focused shock wave inside a fluid filled compliant balloon.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a view of the therapeutic end of a typical prior art over-the-wire angioplasty balloon catheter 10. Such catheters are usually non-complaint with a fixed maximum dimension when expanded with a fluid such as saline.

FIG. 2 is a view of a dilating angioplasty balloon catheter 20 according to an embodiment of the invention. The catheter 20 includes an elongated carrier, such as a hollow sheath 21, and a dilating balloon 26 formed about the sheath 21 in sealed relation thereto at a seal 23. The balloon 26 forms an annular channel 27 about the sheath 21 through which fluid, such as saline, may be admitted into the balloon to inflate the balloon. The channel 27 further permits the balloon 26 to be provided with two electrodes 22 and 24 within the fluid filled balloon 26. The electrodes 22 and 24 are attached to a source of high voltage pulses 30. The electrodes 22 and 24 are formed of metal, such as stainless steel, and are placed a controlled distance apart to allow a reproducible arc for a given voltage and current. The electrical arcs between electrodes 22 and 24 in the fluid are used to generate shock waves in the fluid. The variable high voltage pulse generator 30 is used to deliver a stream of pulses to the electrodes 22 and 24 to create a stream of shock waves within the balloon 26 and within the artery being treated (not shown). The magnitude of the shock waves can be controlled by controlling the magnitude of the pulsed voltage, the current, the duration and repetition rate. The insulating nature of the balloon 26 protects the patient from electrical shocks.

The balloon 26 may be filled with water or saline in order to gently fix the balloon in the walls of the artery in the direct proximity with the calcified lesion. The fluid may also contain an x-ray contrast to permit fluoroscopic viewing of the catheter during use. The carrier 21 includes a lumen 29 through which a guidewire (not shown) may be inserted to guide the catheter into position. Once positioned the physician or operator can start with low energy shock waves and increase the energy as needed to crack the calcified plaque. Such shockwaves will be conducted through the fluid, through the balloon, through the blood and vessel wall to the calcified lesion where the energy will break the hardened plaque without the application of excessive pressure by the balloon on the walls of the artery.

FIG. 3 is a schematic of the high voltage pulse generator 30. FIG. 3A shows a resulting waveform. The voltage needed will depend on the gap between the electrodes and generally 100 to 3000 volts. The high voltage switch 32 can be set to control the duration of the pulse. The pulse duration will depend on the surface area of the electrodes 22 and 24 and needs to be sufficient to generate a gas bubble at the surface of the electrode causing a plasma arc of electric current to jump the bubble and create a rapidly expanding and collapsing bubble, which creates the mechanical shock wave in the balloon. Such shock waves can be as short as a few microseconds.

FIG. 4 is a cross sectional view of the shockwave catheter 20 showing an arc 25 between the electrodes 22 and 24 and simulations of the shock wave flow 28. The shock wave 28 will radiate out from the electrodes 22 and 24 in all directions and will travel through the balloon 26 to the vessel where it will break the calcified lesion into smaller pieces.

FIG. 5 shows another dilating catheter 40. It has insulated electrodes 42 and 44 within the balloon 46 displaced along the length of the balloon 46.

FIG. 6 shows a dilating catheter 50 with an insulated electrode 52 within the balloon 56. The electrode is a single electrode pole in the balloon, a second pole being the ionic fluid 54 inside the balloon. This unipolar configuration uses the ionic fluid as the other electrical pole and permits a smaller balloon and catheter design for low profile balloons. The ionic fluid is generator 30.

FIG. 7 is another dilating 60 catheter with electrodes 62 and 64 within the balloon 66 and studs 65 to reach the calcification. The studs 65 form mechanical stress risers on the balloon surface 67 and are designed to mechanically conduct the shock wave through the intimal layer of tissue of the vessel and deliver it directly to the calcified lesion.

FIG. 8 is another dilating catheter 70 with electrodes 72 and 74 within the balloon 76 and with raised ribs 75 on the surface 77 of the balloon 76. The raised ribs 75 (best seen in FIG. 8A) form stress risers that will focus the shockwave energy to linear regions of the calcified plaque.

FIG. 9 is a further dilating catheter 80 with electrodes 82 and 84 within the balloon 86. The catheter 80 further includes a sensor 85 to detect reflected signals. Reflected signals from the calcified plaque can be processed by a processor 88 to determine quality of the calcification and quality of pulverization of the lesion.

FIG. 10 is a pressure volume curve of a prior art balloon breaking a calcified lesion. FIG. 10B shows the build up of energy within the balloon (region A to B) and FIG. 10C shows the release of the energy (region B to C) when the calcification breaks. At region C the artery is expanded to the maximum dimension of the balloon. Such a dimension can lead to injury to the vessel walls. FIG. 10A shows the initial inflation of the balloon.

FIG. 11 is a pressure volume curve showing the various stages in the breaking of a calcified lesion with shock waves according to the embodiment. The balloon is expanded with a saline fluid and can be expanded to fit snugly to the vessel wall (Region A) (FIG. 11A) but this is not a requirement. As the High Voltage pulses generate shock waves (Region B and C) extremely high pressures, extremely short in duration will chip away the calcified lesion slowly and controllably expanding the opening in the vessel to allow blood to flow un-obstructed (FIG. 11B).

FIG. 12 shows, in a cutaway view, shock waves 98 delivered in all directions through the wall 92 of a saline filled balloon 90 and intima 94 to a calcified lesion 96. The shock waves 98 pulverize the lesion 96. The balloon wall 92 may be formed of non-compliant or compliant material to contact the intima 94.

FIG. 13 shows calcified plaque 96 pulverized by the shock waves. The intima 94 is smoothed and restored after the expanded balloon (not shown) has pulverized and reshaped the plaque into the vessel wall.

FIG. 14 is a schematic of a circuit 100 that uses the generator circuit 30 of FIG. 3 and a surface EKG 102 to synchronize the shock wave to the “R” wave for treating vessels near the heart. The circuit 100 includes an R-wave detector 102 and a controller 104 to control the high voltage switch 32. Mechanical shocks can stimulate heart muscle and could lead to an arrhythmia. While it is unlikely that shockwaves of such short duration as contemplated herein would stimulate the heart, by synchronizing the pulses (or bursts of pulses) with the R-wave, an additional degree of safety is provided when used on vessels of the heart or near the heart. While the balloon in the current drawings will provide an electrical isolation of the patient from the current, a device could be made in a non-balloon or non-isolated manner using blood as the fluid. In such a device, synchronization to the R-wave would significantly improve the safety against unwanted arrhythmias.

FIG. 15 shows a still further dilation catheter 110 wherein a shock wave is focused with a parabolic reflector 114 acting as one electrode inside a fluid filled compliant balloon 116. The other electrode 112 is located at the coaxial center of the reflector 114. By using the reflector as one electrode, the shock wave can be focused and therefore pointed at an angle (45 degrees, for example) off the center line 111 of the catheter artery. In this configuration, the other electrode 112 will be designed to be at the coaxial center of the reflector and designed to arc to the reflector 114 through the fluid. The catheter can be rotated if needed to break hard plaque as it rotates and delivers shockwaves.

The subject method can be used with various electrode designs. For example, the electrodes can be provided with a low profile to improve the ability of the catheter to navigate small vessels. An example of such a low profile electrode design can be found in U.S. Pat. No. 8,747,416. It may also desirable to adjust the length of the voltage pulses to reduce excess heat generation. One approach for achieving this goal is described in U.S. Pat. No. 8,728,091.

While particular embodiments of the present invention have been shown and described, modifications may be made. For example, instead of manual actuation and spring loaded return of the valves used herein, constructions are possible which perform in a reversed manner by being spring actuated and manually returned. It is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention as defined by those claims. 

1. A two-stage method for treating calcified lesions within a wall of a blood vessel in a patient, the method comprising: i) breaking apart a calcified lesion within the wall of the blood vessel using a plurality of shockwaves generated in an angioplasty balloon of an angioplasty catheter device, wherein the angioplasty catheter device includes a guidewire sheath and is disposed on a guidewire while the angioplasty balloon is dilated via a fluid to a first extent to fit against at least a portion of the wall of the blood vessel, and breaking apart the calcified lesion comprises delivering, via a pulse generator, a plurality of electrical pulses to an electrode pair disposed within the angioplasty balloon and exposed to the fluid, each pulse having an amplitude sufficient to create a plasma in the fluid, wherein the plurality of pulses create a plurality of plasma arcs at the electrode pair such that the plurality of shockwaves is conducted through the fluid and through the angioplasty balloon to the blood vessel, thereby delivering mechanical energy to the calcified lesion to crack the calcified lesion; and ii) after breaking apart the calcified lesion, allowing the angioplasty balloon to further expand to a second extent greater than the first extent, thereby redistributing particles of the calcified lesion in the wall of the blood vessel and reshaping an opening in the blood vessel.
 2. The method of claim 1, wherein delivering the plurality of pulses comprises varying, between a series of two pulses of the plurality of pulses, at least one of a pulse duration or a voltage magnitude to alter a shockwave intensity.
 3. The method of claim 1, wherein delivering the plurality of pulses comprises varying, during delivery, a repetition rate of the plurality of pulses.
 4. The method of claim 1, wherein the amplitude of each pulse of the plurality of pulses is within a range of 100 to 3000 volts.
 5. The method of claim 1, wherein the amplitude of each pulse of the plurality of pulses is within a range of 1000 to 3000 volts.
 6. The method of claim 1, wherein the plurality of shockwaves each travel radially through the fluid and through the angioplasty balloon, the plurality of shockwaves delivering energy through an extent of the angioplasty balloon from a proximal end of the angioplasty balloon to a distal end of the angioplasty balloon.
 7. The method of claim 1, wherein allowing the angioplasty balloon to further expand comprises smoothing an intima of the blood vessel.
 8. The method of claim 1, wherein allowing the angioplasty balloon to further expand comprises smoothing and restoring an intima of the blood vessel.
 9. The method of claim 1, wherein cracking the calcified lesion comprises focusing the plurality of shockwaves.
 10. The method of claim 1, wherein cracking the calcified lesion comprises detecting a cardiac R wave of a heart of the patient and wherein creating the plurality of plasma arcs comprises synchronizing each arc of the plurality of plasma arcs with the cardiac R wave.
 11. The method of claim 1, wherein cracking the calcified lesion comprises pulverizing at least a portion of the calcified lesion.
 12. The method of claim 1, wherein the electrode pair is disposed radially external to the guidewire sheath.
 13. The method of claim 1, wherein the distal end of the guidewire sheath extends beyond the distal end of the balloon.
 14. The method of claim 1 wherein when the angioplasty balloon is dilated to the first extent, the angioplasty balloon fits snugly against the wall of the blood vessel.
 15. A method of treating calcified lesions within the wall of a blood vessel comprising: inserting a guide wire into the blood vessel; advancing an angioplasty catheter into the blood vessel over the guide wire, said angioplasty catheter having a guidewire sheath, a fluid-fillable angioplasty balloon, and a shockwave generator located within the angioplasty balloon, wherein the shockwave generator is defined by a pair of spaced apart electrodes disposed inside the angioplasty balloon and exposed to the fluid; expanding the angioplasty balloon with the fluid so that the angioplasty balloon presses against at least a portion of a calcified wall of the blood vessel; after the expanding, supplying one or more electrical pulses to the shockwave generator, each pulse sufficient to create a plasma arc between the pair of spaced apart electrodes resulting in a mechanical shock wave within the angioplasty balloon that passes through the fluid, through the angioplasty balloon, and into the calcified wall of the blood vessel to crack calcified lesions within the calcified wall of the blood vessel; and after the supplying, further expanding the balloon to displace fractured calcification in the wall of the blood vessel, thereby reshaping the blood vessel.
 16. The method of claim 15, further comprising detecting cardiac R waves of the patient's heart, wherein supplying the one or more electrical pulses comprises timing the one or more electrical pulses to synchronize the mechanical shock waves with the detected R waves.
 17. The method of claim 15, wherein the angioplasty balloon is radially symmetric about a longitudinal axis of the angioplasty catheter, wherein the guide wire sheath surrounds the longitudinal axis.
 18. The method of claim 15, wherein the electrode pair are disposed radially external to the guidewire sheath.
 19. The method of claim 15, wherein the distal end of the guidewire sheath extends beyond the distal end of the balloon.
 20. The method of claim 15, wherein when the angioplasty balloon is initially expanded, the angioplasty balloon fits snugly against the wall of the blood vessel. 